MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

Device Problem Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis (pd) patient reported that for the past week they have noticed that their cycler's heater tray has been getting hot enough to cause the heater bag to melt or stick to the tray.The patient received a heater alarm the night before the event was reported.The cycler is not responding to button presses.There is no heating source near the cycler.The cycler is plugged into a three prong wall outlet.The technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.A replacement cycler was issued to the patient.It was reported that an alternate treatment option was available.Additional information has been requested, however, to date a response has not been received.The reported cycler was scheduled to be returned to the manufacturer for physical evaluation.The date of event reported is the date the patient alleged the issue began.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.There were no visual indications of dried fluid within the cassette compartment.There were no visual indications of particulates within the cassette area.There were no burrs or sharp edges in the cassette area that could have punctured the cassette membrane.An as received simulated therapy was initiated and completed on the cycler without complication.The cycler underwent and passed a system air leak test, load cell verification, and valve actuation testing.The cycler passed the temp test, heater test and heater calibration diagnostics checks.Intermittently, the heater tray improperly did not turn off heat when the 5000 gram weight was removed.The fault was repaired by replacing the i/o control board.Removed functioning i/o control board at the completion of the investigation.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.The cycler tested negative for glucose.An internal visual inspection identified evidence of dried fluid within the recess of the bottom cover adjacent to the pump.The cause of the dried fluid could not be determined.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, the reported issue was confirmed and the cause was determined to be a failure of the i/o board.The cycler was refurbished following the evaluation.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 9309276
• MDR Text Key: 169226921
• Report Number: 2937457-2019-03369
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2019
• Device Age: MO
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET